Pulsed Field Ablation for Early Atrial Fibrillation Using a Balloon

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized trial comparing first-line pulsed field ablation (PFA) using a balloon to standard medical therapy in adults with symptomatic or asymptomatic early-stage paroxysmal or persistent AF (<3 years). The study uses an open-label design with blinded end-points and follows participants for 12 months. Eligible patients have no prior AF ablation and meet specific rhythm and medical criteria; key exclusions include longer-standing AF and certain comorbidities. PFA aims to selectively ablate myocardial tissue while minimizing collateral injury, potentially improving safety and efficacy compared with traditional thermal ablation or medical therapy. The trial is sponsored by Asklepios proresearch with collaborators and spans several European centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation
* First diagnosis of AF within the last 36 months
* At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device
* No prior catheter ablation for AF

Exclusion Criteria:

* Persistent AF \>3 years or longstanding persistent AF
* Previous AF-Ablation
* Ongoing continuous AAD therapy with Amiodarone at baseline
* History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy
* Left Atrial Volume Index (LAVI) \> 50mL/m2
* Severe mitral regurgitation
* Contraindications to anticoagulation therapy
* Severe pulmonary or renal disease
* Pregnancy, active cancer disease
* Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)

Where it's running

• Arian Sultan
  Hamburg, Germany Recruiting
• Lukas Krankenhaus Neuss
  Neuss, Germany Recruiting
• HZD Bad Oeynhausen
  Bad Oeynhausen, Germany Not yet recruiting
• Uniklinik Köln
  Cologne, Germany Not yet recruiting
• Uniklinik Düsseldorf
  Düsseldorf, Germany Not yet recruiting
• CCB Frankfurt
  Frankfurt, Germany Not yet recruiting

Study contacts

• Principal investigator: Arian Sultan, MD — Asklepios Klinik St. Georg
• Study coordinator: Kathrin Heitmann
• Email: ka.heitmann@asklepios.com
• Phone: +49 40 181885

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

• 4D intracardiac echocardiography to guide left atrial appendage occlusion procedures

  A new 4D ICE catheter is being tested alongside standard imaging to see if it can safely guide left atrial appendage occlusion procedures for adults with atrial fibrillation.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07806890

• Thoracoscopic vs Catheter Ablation as the First Rhythm Control in Atrial Fibrillation with a Large Left Atrium

  This trial tests whether thoracoscopic surgical ablation is better at keeping atrial fibrillation under control than catheter ablation in people with persistent AF and a large left atrium who have not had an ablation before.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07783984

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.